Mli Set
FDA 510(k) K952392 · Medical Technologies of Georgia
510(k) numberK952392
Submission
- Device name
- Mli Set
- Applicant
- Medical Technologies of Georgia
Decatur, GA, US - Received
- May 22, 1995
- Decision date
- August 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080878 | MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit)KOD · Traditional | 07/17/2008SE |
| K973120 | Readycath CatheterGBM · Traditional | 02/25/1998SE |
| K911129 | MMG Bile BagEXF · Traditional | 08/07/1991SE |
| K873136 | MMG Cath-N-PlaceKNX · Traditional | 09/09/1987SE |
| K871949 | MMG Delee Suction Catheter W/Mucous TrapBSY · Traditional | 06/15/1987SE |
| K854821 | MMG External Female CathetersKNX · Traditional | 04/24/1986SE |
| K854660 | The MMG Enteral Feeding Administration SetKNT · Traditional | 01/21/1986SE |
| K840839 | MMG Foley CatheterKOD · Traditional | 04/17/1984SE |
| K840897 | Oxygen TubingCAT · Traditional | 03/16/1984SE |
| K821854 | U-200 BagKNX · Traditional | 07/22/1982SE |
Questions and answers
When was Mli Set cleared by the FDA?
Mli Set (K952392) received a 510(k) decision of Substantially Equivalent on August 7, 1995, 77 days after the submission was received.
What is the product code of K952392?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.